NCT03435679

One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty

One-stage Versus Two-stage Revision of the Infected Knee Arthroplasty. a Randomized Controlled Multicenter Trial.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Odense University Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study investigates functional outcome and safety after one-stage versus two-stage revision of the infected knee arthroplasty. Half of participants are treated with a one-stage surgical procedure, while the other half is treated with a two-stage procedure. The investigators hypothesize that the functional outcome and quality of life of the participants is superior after one-stage surgery compared to two-stage surgery.

Detailed description

A two-stage approach is the standard surgical procedure in the treatment of the chronically infected knee arthroplasty, but promising results have been reported after a one-stage approach from single-centre studies. The potential benefits for the patients treated with a one-stage approach are many as they only have to go through surgery and rehabilitation once with shorter total length of hospital stay. However, no randomized controlled trials comparing outcome after the procedures have been performed so far.

Conditions

• Periprosthetic Knee Infection

Interventions

Type	Name	Description
PROCEDURE	one-stage	one-stage surgery
PROCEDURE	two-stage	two-stage surgery

Timeline

• Start date: 2018-03-01
• Primary completion: 2025-11-18
• Completion: 2026-11-18
• First posted: 2018-02-19
• Last updated: 2024-12-11

Locations

9 sites across 1 country: Denmark